Site Quality Director

hace 23 horas

Alajuela, Costa Rica Abbott Laboratories A tiempo completo

**About Abbott**

Abbott is a global healthcare leader, creating breakthrough science to improve people's health.
We're always looking towards the future, anticipating changes in medical science and technology.
**Working at Abbott**

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.
You will have access to:

- Career development with an international company where you can grow the career you dream of.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
**The Opportunity**

This position works out of Costa Rica located in the Medical Devices line of business for the Electrophysiology (EP) Division.
In Abbott's Electrophysiology business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
As Site Quality Director, this role will be required to foster a culture of cross-functional alignment and compliant problem-solving.
This role is responsible for developing strategies that result in robust and streamlined Production and Process Controls while partnering with the development team to incorporate improvements into future product designs.
They will be responsible for ensuring Abbott provides world-class devices conforming to established requirements and specifications, built following validated processes to meet our customer needs.
The Site Quality Director is the site-level Quality Management representative, who will champion the manufacturing quality system requirements and ensure they are effectively established and maintained as well as report on the performance of the quality system to management with executive responsibility.
**What You'll Do**
- Provide overall site direction and leadership for product quality and compliance.
- Serves as the primary site Management Representative for external regulatory inspections and audits.
- Oversee the development, implementation, improvement, and monitoring of quality processes and procedures to ensure that a device conforms to its specifications
- Provide leadership and define organizational activities in support of the Product Development Process
- Identifies and manages activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
- Oversee the CAPA, Nonconformance, and Real-time data management portions of the Quality System
- Champion post-production risk management activities to include complaint investigation, risk analysis, and action deployment to resolve any issues.
- Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic, and international quality regulations, including EN ISO 13485, 21CFR 820 Quality System Regulation, MDD, JPAL, and CMDR.
- Ensures that product acceptance activities are handled in a manner that complies with all pertinent regulatory requirements.
Reports on the performance of the quality system.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Be an effective member of the cross-functional Director organization to foster a culture of continuous quality compliance, cost, and predictive measures improvements.
- Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback and development opportunities.
Sets goals which align with department plans and manages the execution of goals through coaching and mentoring.
Maintains a safe and professional work environment.
**Required Qualifications**
- Bachelor's Degree in Engineering, Sciences or other related fields; Master's Degree preferred
- Minimum of 10 years of experience at progressive work in medical device or high technology industries.
Minimum of 5 years prior management experience
- Fluent in English and Spanish
- Strong negotiation skills.
- Strong verbal and written communication with the ability to effectively communicate at multiple levels in the organization.
Multitasks prioritizes and meets deadlines in a timely manner.
- Demonstrated ability to understand/ familiarity with applicable FDA and BSI regulations, and other relevant clinical/regulatory requirements.
Class III or II medical device background in a Quality Leadership role.
Quality System Regulations knowledge (ISO 9001, ISO 13485).
Demonstrated ability to create relationships, influence and move critical projects forwa

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